FDA.reportPublic FDA data

Bone-screw internal spinal fixation system, sterile

Definition
An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.
GUDID devices
24,367
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03663422000057Mont Blanc Spinal SystemsSPINEWAY12016-09-08
03663422000064Mont Blanc Spinal SystemsSPINEWAY12016-09-08
03663422000071Mont Blanc Spinal SystemsSPINEWAY12016-09-08
03663422000088Mont Blanc Spinal SystemsSPINEWAY12016-09-08
03663422000095Mont Blanc Spinal SystemsSPINEWAY12016-09-08
03663422000101Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000125Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000132Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000149Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000156Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000163Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000170Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000187Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000194Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000200Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000217Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000224Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000231Mont Blanc Spinal SystemsSPINEWAY12016-08-08
03663422000248Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000255Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000262Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000279Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000286Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000293Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000309Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000316Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000323Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000330Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000347Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000354Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000361Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000378Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000385Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000392Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000408Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000415Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000422Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000439Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000446Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000453Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000460Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000477Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000484Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000491Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000507Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000514Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000521Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000538Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000545Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000552Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000569Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000576Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000583Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000590Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000606Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000613Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000620Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000637Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000644Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000651Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000668Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000675Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000705Mont Blanc Spinal SystemsSPINEWAY12016-09-08
03663422000712Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000729Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000736Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000743Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000750Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000767Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000774Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000781Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000798Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000804Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000811Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000828Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000835Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000842Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000859Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000866Mont Blanc Spinal SystemsSPINEWAY12016-08-09
03663422000873Mont Blanc Spinal SystemsSPINEWAY12016-08-09